CBL-514 Injection for Reducing Subcutaneous Fat

(SUPREME-01 Trial)

Not yet recruiting at 25 trial locations

Overseen By Candra Chou

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Caliway Biopharmaceuticals Co., Ltd.

Must not be taking: Weight loss drugs, GLP-1 agonists

Disqualifiers: Pregnancy, Diabetes, Malignancies, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called CBL-514, which aims to reduce subcutaneous belly fat. Researchers seek to determine if this injection is safe and effective compared to a placebo, a harmless solution resembling the actual treatment. It targets individuals with moderate to severe belly fat who maintain a stable lifestyle. Those with a fear of needles or certain medical conditions may not be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any weight reduction medications, GLP-1 agonists, long-term systemic steroids, immunosuppressive therapy, and certain medications affecting CYP1A2 enzymes. If you're on these, you may need to stop them to participate.

Is there any evidence suggesting that CBL-514 injection is likely to be safe for humans?

Research has shown that CBL-514 injections are generally safe and well-tolerated. Studies indicate that CBL-514 can significantly reduce belly fat without causing major side effects. Most participants did not experience serious problems, and the treatment received positive feedback. Some mild reactions, such as slight pain or redness at the injection site, might occur, but these are usually temporary. Overall, the safety data appears promising for those considering joining a trial for CBL-514. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for reducing subcutaneous fat, which often involve surgical procedures like liposuction or non-surgical methods such as cryolipolysis, CBL-514 is a non-surgical injectable solution. Researchers are excited about CBL-514 because it breaks down fat cells through a unique chemical process, potentially offering a less invasive option with minimal recovery time. This approach could provide a more convenient and accessible alternative for individuals looking to reduce fat without undergoing surgery.

What evidence suggests that CBL-514 injection might be an effective treatment for reducing abdominal subcutaneous fat?

Research has shown that CBL-514 injections, which participants in this trial may receive, can help reduce body fat under the skin. One study found that many people lost at least 150 mL of fat within 4 to 8 weeks after receiving the treatment. Another study demonstrated that CBL-514 outperformed liposuction, with some individuals losing over 300 mL of fat. The treatment appears effective in various body areas, even with just one injection. These findings suggest that CBL-514 could be a promising option for reducing stubborn body fat. ^{4 6 7 8 9}

Who Is on the Research Team?

Anne Sheu

Principal Investigator

Caliway Biopharmaceuticals Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for individuals looking to reduce abdominal subcutaneous fat. Specific eligibility criteria are not provided, but typically participants should be healthy adults who meet certain body mass index (BMI) requirements and have a stable weight.

Inclusion Criteria

Body mass index (BMI) > 18.5 and < 30 kg/m2 and body weight ≥ 50 kg

I am willing and able to follow the study's procedures.

Participant maintained a stable lifestyle

Exclusion Criteria

I have cancer or am being checked for cancer.

I am on long-term steroids or immunosuppressants.

I am not pregnant or breastfeeding and agree to use birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 4 treatments of the study drug or placebo, administered subcutaneously to the abdomen every 3 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBL-514 Injection

Trial Overview The study tests the effectiveness of CBL-514 Injection compared to a placebo (0.9% Sodium Chloride). It's randomized, meaning people are put into the treatment or placebo group by chance, and double-blinded so neither participants nor researchers know who's getting what.

How Is the Trial Designed?

Group I: CBL-514 injection Experimental Treatment 1 Intervention

Participants will receive CBL-514 administrated up to 120 mL (with 50 injections) per treatment at a 3-weeks interval for up to 4 treatments.

Group II: Injectable 0.9% Sodium Chloride solution Placebo Group 1 Intervention

Participants will receive 0.9% Sodium Chloride administrated up to 120 mL (with 50 injections) per treatment at a 3-week interval for up to 4 treatments.

Who Is Running the Clinical Trial?

Caliway Biopharmaceuticals Co., Ltd.

Lead Sponsor

Trials

11

Recruited

550+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9384315/

A Randomized, Phase IIa Study of CBL-514 Injection on ... We therefore expect CBL-514 to produce favorable outcomes in subcutaneous fat reduction in other body areas, regardless of size. With only 1 injection ...

2. academic.oup.com academic.oup.com/asj/article/45/6/611/8051634

Efficacy and Safety of CBL-514 Injection in Reducing ... The primary efficacy outcome was the proportion of participants exhibiting ≥150 mL subcutaneous fat volume loss from baseline to the 4- and 8-week follow-up ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06005441

NCT06005441 | A Phase 2b Study to Evaluate the Efficacy ... This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 ...

4. caliwaybiopharma.com caliwaybiopharma.com/en/news-detail/cbl-0202-met-efficacy-endpoints/

Caliway's CBL-514 Achieved Better Efficacy than ... CBL-514 demonstrated the efficacy on subcutaneous fat reduction more effective than liposuction in the CBL-0202 stage 2 phase 2 study, reducing over 300mL of ...

5. prnewswire.com prnewswire.com/news-releases/caliway-to-present-cbl-514-phase-2b-study-results-for-subcutaneous-fat-reduction-at-imcas-2025-in-paris-302335697.html

Caliway to Present CBL-514 Phase 2b Study Results for ... The data will be highlighted in both the 2025 focus session on advances in fat reduction therapies and further detailed in the Non-surgical Body ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080885/

Efficacy and Safety of CBL-514 Injection in Reducing ... CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04698642

NCT04698642 | A Study to Evaluate the Safety, Tolerability ... A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat.

8. caliwaybiopharma.com caliwaybiopharma.com/en/research/15/

CBL-514-R&D-Caliway Biopharmaceuticals Co., Ltd Administered via subcutaneous injection, CBL-514 has demonstrated a favorable safety and tolerability profile, enabling significant localized fat reduction ...

9. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378399

ANZCTR - Registration CBL-514 will be administered via injection into the abdominal subcutaneous adipose layer. Eligible subjects will be randomized to 1 of 3 treatment groups: ...